The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)

The University of Texas System (UT)

Status

Not yet enrolling

Conditions

Cerebral Palsy

Treatments

Dietary Supplement: commercial blenderized tube feed (CBTF)

Dietary Supplement: commercial formulas (CF)

Study type

Interventional

Funder types

Other

Identifiers

NCT06488560

HSC-MS-24-0047

Details and patient eligibility

About

The purpose of this study is to compare the Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scale Gastrointestinal Symptoms Scale (GI-PedsQL) differences , to assess the differences in stool microbiome and stool metabolomics , to assess differences in salivary cytokine profile , to assess differences in weight change , to compare the use of antacid medications and to compare the use of laxative medications in patients on commercial formulas (CF) versus commercial blenderized tube feed (CBTF).

Enrollment

40 estimated patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with CP receiving >75% of total daily caloric requirements from commercial formulas (CF) via a gastrostomy tube 12french or greater
Patients' insurance covers a CBTF
Diagnosis of cerebral palsy

Exclusion criteria

Receiving enteral nutrition by transpyloric feeds or jejunal tube.
Receiving <75% of total daily energy requirements from a commercial formula
Weight or weight for length or body mass index less than the 5th percentile for age or greater than the 85th% percentile for age when plotted on the cerebral palsy growth chart
Rapidly progressive neurodegenerative disease diagnosis
Use of monomeric formulas